SPL Process Team - Generic Drugs Subgroup Meeting Aug 25 2008, 1pm EDST Meeting Minutes -------------------------------------------------------------------------------------------------------------------- Proposed agenda: 1. Meeting minutes – Any Questions? OK to send out names, business and e-mails with minutes?Will not send out titles or phone numbers. 2. Training Opportunities: Upcoming DIA Meetings: September 9, 2008 – SPL webinar End of October – 1 ½ day face-to-face SPL meeting – Oct 29 & 30 in Philadelphia Upcoming GpHA Meeting: October 28-30, 2008 - Fall Technical Workshop - 1 day SPL face-to-face meeting on October 28th in DC 3. Further discussion of drug listing, read X-form prior to meeting to be prepared. We will put together a list of scenarios/situations that you have questions about and send them to the FDA. 4. What is Wiki anyway? - Jeffery Karp brief discussion. 5. Q & A: VH is working with Michael Fahmy to establish a Q&A format for Wiki. A few questions I received from team members: Q1. I had thought that I heard FDA saying, more than once, that they want to know who the supplier of the API(s) in a product are.But when I look at the Xform, there is no place where you indicate the supplier of the API. Q2. I have contacted Dunn and Bradstreet regarding obtaining the Dunn's # for our vendors.Is there a way to obtain this information on line or must you request a full credit report on each of your vendors which would then provide you with the Dunn's #'s. Q3. On instructions for using Electronic Drug Establishment Registration and Drug Listing, XForms v1.0: 4.5 Establishment The establishments are the entities involved in the manufacturing or processing the drug product.Enter one or more establishments.This information includes the name, DUNS Number and types of operations. How many levels do we need to supply? 6. Need to get comments on the Guidance to FDA by Monday Sept 8th.Need comments to me by the end of this week. 7. Next meeting is September 8 at 1:00 pm. -------------------------------------------------------------------------------- The agenda was followed closely. Jeffery Karp (GeronMed) taking notes Summary: 1. Meeting Minutes There were no questions or comments on the minutes. There were no objections to publishing the group member list. 2. Training A list of opportunities was included in the agenda. If the difficult choice arises of which meeting to attend, the following pieces of information may help: The DIA meeting is more general and will draw more vendors. The GpHA meeting will be more specific in addressing the needs of the Generic Pharma companies. 3. XForms A great deal of discussion regarding the use of XForms for establishment registration.One company with many products and many establishments noted several objections with using the free tool.
There is no support from the FDA or GlobalSubmit (the vendor) for XForms beyond the instructions.
The FDA says and the company concurs that the software was setup as a test and not for a full production environment for a company with many products.
The same sponsor company found it difficult to get other vendor support to do the SPL R4 work as well.They are currently in the process of interviewing vendors to find a solution.This company is very concerned that they may not find a solution in a sufficiently timely fashion and are in the process of requesting a time extension for implementation of the rule. It was also noted that XForms is not validated and would be difficult to validate. There is no need to get a DUNS number if the establishment is already registered.The NDC for that may be used. 4. Wiki Jeffery Karp (GeronMed, RA-IT Assoc) gave a brief introduction to the Wiki that is in-process. A wiki should always be in-process.The word means “quick” in Hawaiian. A wiki is computer server software that allows users to easily create, edit and link web pages. Wikis are often used to create collaborativewebsites, power community websites, and are increasingly being installed by businesses to provide affordable and effective Intranets or for use in Knowledge Management. Ward Cunningham, developer of the first wiki, WikiWikiWeb, originally described it as "the simplest online database that could possibly work".[1] One of the best-known wikis is Wikipedia.[2] Quote from Answers.com The wiki for the process team and the subgroups is http://spl-work-group.wikispaces.com Please go there and try it out.We appreciate any feedback. There are sections in the wiki for the Generics subgroup as well as the other subgroups.There are also sections for processes and FAQs (Frequently Asked Questions).Any page may have discussion items added. Currently, leaders of each group and the wikimaster can make changes and add additional pages. FDA documents for comments have been placed on the site.The document, “Draft Guidance - Providing Regulatory Submissions in Electronic Format of Drug Establishment Registration and Drug Listing”is available at: http://spl-work-group.wikispaces.com/Draft+Guidance+-+Electronic+Submission+of+Establishment+Registration+and+Drug+Listing Comments may be left by using the discussion tab.The same is true for comments on any of the wiki pages.Comments for this document are needed quickly. 5. Q&A Q1. I had thought that I heard FDA saying, more than once, that they want to know who the supplier of the API(s) in a product are.But when I look at the Xform, there is no place where you indicate the supplier of the API. A1. You put it in the establishment field.You don’t have to note that it is an API.(You can only list a product or an establishment in this field.) Q2. I have contacted Dunn and Bradstreet regarding obtaining the Dunn's # for our vendors.Is there a way to obtain this information on line or must you request a full credit report on each of your vendors which would then provide you with the Dunn's #'s? A2. Several parts of the answer were given at the meeting, including discussion of how to register with Dun and Bradstreet, and basic costs.A response from Sue Halleran who added a great deal to the discussion came in yesterday.This more complete discussion appears below: Following up with you and the information I shared at the Teleconference yesterday. In regard to obtaining the DUN's registration No. As I stated this has been a very time consuming task. I pulled a complete vendor list from our system, and started working off that. Our Accounting Department was kind enough to advise me what vendors we no longer use. This whole process was started on August 8, 2008, and at this time I have contacted all our vendors, and have received approximately 3/4 of the DUN's registration No. from our vendors. All have been very cooperative, and those that have had additional questions they have e-mailed or called and after explaining the whole situation, have been very understanding. I am right now doing all my follow-ups to those who have not yet responded. I have contacted ALL vendors, - API's and excipients as at the time the decision was not firm whether we were just to use the API's.
The actual cost was 3500.00 for the first 50 reports, after speaking with Tom at DUNN and BRADSTREET he advised he would give us a 10% discount for each 25 reports after that.
Should you need anything further or I can help anyone regarding this please feel free to contact me and I will be glad to help anyone with this.
Thank you
Sue Halleran
Virginia followed up with 2 questions: Q2.1Do you have a form letter that you send to your vendors that you would be willing to share? A2.1 My e-mail basically stated: DUN"s Registration No. - I would like to request your DUN's registration No. (D&B #) we now must include this on our correspondence to the Food and Drug Administration regarding drug establishment listing and registrations. - We currently are receiving from you. Should you have any further questions or concerns regarding this please feel free to contact me. Q2.2 It would also help is if we know how many products that you were working from, how many vendors you contacted (I think you said 250?) and how many hours you have spent on this to get 75% finished. (Also, the last 25% may be the hardest since you have not heard from them yet.) A2.2 Once I get the complete list done I will be able to give you an accurate number as to how many companies I contacted and how many products that involved. Q3. On instructions for using Electronic Drug Establishment Registration and Drug Listing, XForms v1.0: 4.5 Establishment The establishments are the entities involved in the manufacturing or processing the drug product.Enter one or more establishments.This information includes the name, DUNS Number and types of operations. How many levels do we need to supply? A3. You need to list anyone that you used in the process to manufacture the product. This discussion was cut short as we had gone over the hour allocated for this meeting.We will discuss this further at the next meeting. 6.Need to get comments on the Guidance to FDA by Monday Sept 8th.Need comments to Virginia by the end of this week. The wiki may be used as well.Gary Saner has volunteered to help collate and assemble the comments. 7. Next meeting is September 8 at 1:00 pm.Please send agenda items to Virginia Hogan.
Aug 25 2008, 1pm EDST
Meeting Minutes
--------------------------------------------------------------------------------------------------------------------
Proposed agenda:
1. Meeting minutes – Any Questions?
OK to send out names, business and e-mails with minutes? Will not send out titles or phone numbers.
2. Training Opportunities:
Upcoming DIA Meetings:
September 9, 2008 – SPL webinar
End of October – 1 ½ day face-to-face SPL meeting – Oct 29 & 30 in Philadelphia
Upcoming GpHA Meeting:
October 28-30, 2008 - Fall Technical Workshop - 1 day SPL face-to-face meeting on October 28th in DC
3. Further discussion of drug listing, read X-form prior to meeting to be prepared. We will put together a list of scenarios/situations that you have questions about and send them to the FDA.
4. What is Wiki anyway? - Jeffery Karp brief discussion.
5. Q & A:
VH is working with Michael Fahmy to establish a Q&A format for Wiki.
A few questions I received from team members:
Q1. I had thought that I heard FDA saying, more than once, that they want to know who the supplier of the API(s) in a product are. But when I look at the Xform, there is no place where you indicate the supplier of the API.
Q2. I have contacted Dunn and Bradstreet regarding obtaining the Dunn's # for our vendors. Is there a way to obtain this information on line or must you request a full credit report on each of your vendors which would then provide you with the Dunn's #'s.
Q3. On instructions for using Electronic Drug Establishment Registration and Drug Listing, XForms v1.0:
4.5 Establishment
The establishments are the entities involved in the manufacturing or processing the drug product. Enter one or more establishments. This information includes the name, DUNS Number and types of operations.
How many levels do we need to supply?
6. Need to get comments on the Guidance to FDA by Monday Sept 8th. Need comments to me by the end of this week.
7. Next meeting is September 8 at 1:00 pm.
--------------------------------------------------------------------------------
The agenda was followed closely.
Jeffery Karp (GeronMed) taking notes
Summary:
1. Meeting Minutes
There were no questions or comments on the minutes.
There were no objections to publishing the group member list.
2. Training
A list of opportunities was included in the agenda.
If the difficult choice arises of which meeting to attend, the following pieces of information may help:
The DIA meeting is more general and will draw more vendors.
The GpHA meeting will be more specific in addressing the needs of the Generic Pharma companies.
3. XForms
A great deal of discussion regarding the use of XForms for establishment registration. One company with many products and many establishments noted several objections with using the free tool.
The same sponsor company found it difficult to get other vendor support to do the SPL R4 work as well. They are currently in the process of interviewing vendors to find a solution. This company is very concerned that they may not find a solution in a sufficiently timely fashion and are in the process of requesting a time extension for implementation of the rule.
It was also noted that XForms is not validated and would be difficult to validate.
There is no need to get a DUNS number if the establishment is already registered. The NDC for that may be used.
4. Wiki
Jeffery Karp (GeronMed, RA-IT Assoc) gave a brief introduction to the Wiki that is in-process.
A wiki should always be in-process. The word means “quick” in Hawaiian.
A wiki is computer server software that allows users to easily create, edit and link web pages. Wikis are often used to create collaborative websites, power community websites, and are increasingly being installed by businesses to provide affordable and effective Intranets or for use in Knowledge Management. Ward Cunningham, developer of the first wiki, WikiWikiWeb, originally described it as "the simplest online database that could possibly work".[1] One of the best-known wikis is Wikipedia.[2]
Quote from Answers.com
The wiki for the process team and the subgroups is
http://spl-work-group.wikispaces.com
Please go there and try it out. We appreciate any feedback.
There are sections in the wiki for the Generics subgroup as well as the other subgroups. There are also sections for processes and FAQs (Frequently Asked Questions). Any page may have discussion items added.
Currently, leaders of each group and the wikimaster can make changes and add additional pages.
FDA documents for comments have been placed on the site. The document, “Draft Guidance - Providing Regulatory Submissions in Electronic Format of Drug Establishment Registration and Drug Listing” is available at:
http://spl-work-group.wikispaces.com/Draft+Guidance+-+Electronic+Submission+of+Establishment+Registration+and+Drug+Listing
Comments may be left by using the discussion tab. The same is true for comments on any of the wiki pages. Comments for this document are needed quickly.
5. Q&A
Q1. I had thought that I heard FDA saying, more than once, that they want to know who the supplier of the API(s) in a product are. But when I look at the Xform, there is no place where you indicate the supplier of the API.
A1. You put it in the establishment field. You don’t have to note that it is an API. (You can only list a product or an establishment in this field.)
Q2. I have contacted Dunn and Bradstreet regarding obtaining the Dunn's # for our vendors. Is there a way to obtain this information on line or must you request a full credit report on each of your vendors which would then provide you with the Dunn's #'s?
A2. Several parts of the answer were given at the meeting, including discussion of how to register with Dun and Bradstreet, and basic costs. A response from Sue Halleran who added a great deal to the discussion came in yesterday. This more complete discussion appears below:
Following up with you and the information I shared at the Teleconference yesterday.
In regard to obtaining the DUN's registration No. As I stated this has been a very time consuming task. I pulled a complete vendor list from our system, and started working off that. Our Accounting Department was kind enough to advise me what vendors we no longer use. This whole process was started on August 8, 2008, and at this time I have contacted all our vendors, and have received approximately 3/4 of the DUN's registration No. from our vendors. All have been very cooperative, and those that have had additional questions they have e-mailed or called and after explaining the whole situation, have been very understanding. I am right now doing all my follow-ups to those who have not yet responded.
I have contacted ALL vendors, - API's and excipients as at the time the decision was not firm whether we were just to use the API's.
The actual cost was 3500.00 for the first 50 reports, after speaking with Tom at DUNN and BRADSTREET he advised he would give us a 10% discount for each 25 reports after that.
Should you need anything further or I can help anyone regarding this please feel free to contact me and I will be glad to help anyone with this.
Thank you
Sue Halleran
Virginia followed up with 2 questions:
Q2.1 Do you have a form letter that you send to your vendors that you would be willing to share?
A2.1 My e-mail basically stated:
DUN"s Registration No. - I would like to request your DUN's registration No. (D&B #) we now must include this on our correspondence to the Food and Drug Administration regarding drug establishment listing and registrations. - We currently are receiving from you.
Should you have any further questions or concerns regarding this please feel free to contact me.
Q2.2 It would also help is if we know how many products that you were working from, how many vendors you contacted (I think you said 250?) and how many hours you have spent on this to get 75% finished. (Also, the last 25% may be the hardest since you have not heard from them yet.)
A2.2 Once I get the complete list done I will be able to give you an accurate number as to how many companies I contacted and how many products that involved.
Q3. On instructions for using Electronic Drug Establishment Registration and Drug Listing, XForms v1.0:
4.5 Establishment
The establishments are the entities involved in the manufacturing or processing the drug product. Enter one or more establishments. This information includes the name, DUNS Number and types of operations.
How many levels do we need to supply?
A3. You need to list anyone that you used in the process to manufacture the product. This discussion was cut short as we had gone over the hour allocated for this meeting. We will discuss this further at the next meeting.
6. Need to get comments on the Guidance to FDA by Monday Sept 8th. Need comments to Virginia by the end of this week.
The wiki may be used as well. Gary Saner has volunteered to help collate and assemble the comments.
7. Next meeting is September 8 at 1:00 pm. Please send agenda items to Virginia Hogan.